Effect of Laser Light alone or in conjunction with Antimicrobial Therapy in the treatment of Mouth Sores in patients with Oral and Oropharyngeal cancer

Not Applicable

Terminated

• Conditions: Head and Neck Neoplasms; Stomatitis; Mouth Neoplasms; Oropharyngeal Neoplasms; C07.465.672

• Registration Number: RBR-63nvsq6
• Lead Sponsor: niversidade Federal de Minas Gerais

Brief Summary

Oral mucositis is a common complication of oral cavity and oropharyngeal cancer treatment. Given the potential aggravation of oral mucositis due to microorganism presence, disinfection provided by antimicrobial photodynamic therapy may be an effective approach. The aim of this study was to evaluate the efficacy of photobiomodulation and antimicrobial photodynamic therapy in treating oral mucositis. Fourteen patients undergoing radiochemotherapy for oral cavity and oropharyngeal cancer, who developed oral mucositis, were included in the study. The control group consisted of 6 patients undergoing only photobiomodulation, while the experimental group included 8 patients undergoing both photobiomodulation and antimicrobial photodynamic therapy. Parameters assessed were lesion size, duration, pain, and microorganism identification. A mean reduction of 0.70 cm2 (±0.35) in oral mucositis size was observed in the experimental group, compared to 0.30 cm2 (±1.10) in the control group. The mean duration of oral mucositis was 18.37 days (±12.12) for the experimental group and 23 days (±14.78) for the control group. The experimental group showed a mean reduction of 3.40 points on the pain scale (±2.44), whereas the control group had a reduction of 0.17 (±2.28). The predominant isolated microbiota in the experimental group was characterized as mixed culture (n = 4/50%), followed by Gram-positive (n = 3/37.50%) and Gram-negative (n = 1/12.55%). In the control group, mixed culture was also the most frequent (n = 4/66%), followed by Gram-positive (n = 2/34%). No predominant isolation of Gram-negative was found in the control group. Although no statistical significance was found between the control and experimental groups, the superior results observed in the experimental group suggest that the combination of photobiomodulation and antimicrobial photodynamic therapy may be a promising alternative in the treatment of oral mucositis lesions.

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-09-30
• Study Start: 2022-02-18
• Results First Posted: 2023-03-27
• Last Update Posted: 5 March 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patient underwent radiotherapy and chemotherapy with concomitant cisplatin; Patients underwent external radiotherapy with conventional fractionation (1.8 Grays day); and received total dose of 60 Grays or more; Over 18 years old.

Exclusion Criteria

Patients with systemic diseases that impair wound healing (diabetes); Patients who cannot understand the research and the Free and Informed Consent Form; Patients with mouth opening difficulties prior to starting the proposed treatment.

Study & Design

• Study Type: Intervention
• Study Design: Not specified